Invanz Side Effects

Generic Name: ertapenem

Note: This document contains side effect information about ertapenem. Some of the dosage forms listed on this page may not apply to the brand name Invanz.

Some side effects of Invanz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ertapenem: injection powder for solution

Along with its needed effects, ertapenem (the active ingredient contained in Invanz) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ertapenem:

More common
  • Bleeding
  • blistering
  • burning
  • coldness
  • diarrhea
  • discoloration of skin
  • feeling of pressure
  • hives
  • infection
  • inflammation
  • itching skin
  • lumps
  • numbness
  • pain
  • redness of skin
  • scarring
  • skin rash
  • soreness
  • stinging
  • swelling
  • tenderness
  • tingling
  • ulceration
  • unusually warm skin
Less common
  • Bluish color changes in skin color
  • dry, red, hot, or irritated skin
  • fast, pounding, or irregular heartbeat or pulse
  • pain, tenderness, or swelling of foot or leg
Rare
  • Abdominal or stomach cramps
  • abdominal tenderness
  • bloating
  • convulsions
  • diarrhea, watery and severe, which may also be bloody
  • fainting or loss of consciousness
  • fast or irregular breathing
  • fever
  • increased thirst
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • nausea
  • sudden loss of consciousness
  • swelling of eyes or eyelids
  • tightness in chest
  • trouble in breathing
  • unusual tiredness or weakness
  • unusual weight loss
  • vomiting
  • wheezing
Incidence not known
  • Cough
  • difficulty swallowing
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seeing, hearing, or feeling things that are not there
  • shortness of breath

Some side effects of ertapenem may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Agitation
  • chest pain
  • confusion about identity, place, and time
  • drowsiness
  • headache
  • mental depression
Less common
  • Acid or sour stomach
  • belching
  • blurred vision
  • body aches or pain
  • congestion
  • difficult or labored breathing
  • difficulty having a bowel movement (stool)
  • dizziness
  • dryness or soreness of throat
  • faintness or lightheadedness when getting up from a lying or sitting position
  • fear
  • flushing
  • heartburn
  • hoarseness
  • indigestion
  • itching of the vagina or genital area
  • lack or loss of strength
  • leg pain
  • nervousness
  • pain during sexual intercourse
  • pounding in the ears
  • runny nose
  • sleeplessness
  • slow heartbeat
  • sore mouth or tongue
  • stomach discomfort, upset, or pain
  • sudden sweating
  • tender, swollen glands in neck
  • thick, white vaginal discharge with no odor or with a mild odor
  • tightness in chest
  • trouble sleeping
  • unable to sleep
  • voice changes
  • white patches in mouth and/or on tongue

For Healthcare Professionals

Applies to ertapenem: injectable powder for injection

General

In general, the most common side effects associated with ertapenem (the active ingredient contained in Invanz) have been considered mild to moderate and have included diarrhea (5.5%), infused vein complication (3.7%), nausea (3.1%), headache (2.2%), and vaginitis in females (2.1%).

Gastrointestinal

Small intestinal obstruction, C difficile infection or colitis, dry mouth, and hematochezia were reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery.

Very common (10% or more): Diarrhea (up to 10.3%)
Common (1% to 10%): Nausea (up to 8.5%), abdominal pain (up to 4.3%), constipation (up to 4%), vomiting (up to 4%), small intestinal obstruction (2.1%)
Uncommon (0.1% to 1%): Greater than 0.5%: Clostridium difficile infection or colitis, dry mouth, hematochezia; Greater than 0.1%: Gastrointestinal hemorrhage, acid regurgitation, dyspepsia, oral candidiasis, anorexia, flatulence, C difficile associated diarrhea, stomatitis, dysphagia, hemorrhoids, ileus, cholelithiasis, duodenitis, esophagitis, gastritis, jaundice, mouth ulcer, pancreatitis, pyloric stenosis, taste perversion

Hepatic

Common (1% to 10%): Increased ALT (up to 8.8%), increased AST (up to 8.4%), increased serum alkaline phosphatase (up to 6.6%)
Uncommon (0.1% to 1%): Increased direct and indirect serum bilirubin (greater than 0.1%)

Local

Common (1% to 10%): Infused vein complication (up to 7.1%)
Uncommon (0.1% to 1%): Greater than 0.1%: Injection site induration, injection site pain, extravasation, phlebitis/thrombophlebitis
Frequency not reported: Tenderness, ecchymosis

Nervous system

Common (1% to 10%): Headache (up to 6.8%), altered mental status (includes agitation, confusion, disorientation, decreased mental acuity, changed mental status, somnolence, stupor; up to 5.1%), insomnia (3.2%), dizziness (up to 2.1%)
Uncommon (0.1% to 1%): Cerebrovascular accident (greater than 0.5%); Greater than 0.1%: Syncope, seizure, tremor, hypesthesia, spasm, paresthesia, vertigo
Postmarketing reports: Coordination abnormal, depressed level of consciousness, dyskinesia, gait disturbance, myoclonus, tremor

Cerebrovascular accident was reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

In clinical trials, seizures were reported in 0.5% of patients, most often in patients with CNS disorders (e.g., brain lesions or seizure history) and/or renal dysfunction. A case report describes a patient on continuous ambulatory peritoneal dialysis who had multiple tonic-clonic seizures after receiving 2 doses of ertapenem.

Hematologic

Common (1% to 10%): Increased platelet count (up to 6.5%), anemia (5.7%), decreased hemoglobin (up to 4.9%), decreased hematocrit (up to 3.4%), increased eosinophils (up to 2.1%)
Uncommon (0.1% to 1%): Greater than 0.1%: Decreased segmented neutrophils, increased prothrombin time, increased PTT, decreased platelet count, decreased WBC
Frequency not reported: Increased monocytes, increased white blood cell count

Anemia was reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Other

Postoperative infection, wound infection, anastomotic leak, seroma, wound complication, wound dehiscence, wound secretion, crepitations, abdominal abscess, fungal rash, pelvic abscess, incision site complication, incision site hemorrhage, and intestinal stoma complication were reported in a study using 1 g of ertapenem (the active ingredient contained in Invanz) for prophylaxis of surgical site infection following elective colorectal surgery.

In patients with complicated intraabdominal infections, death occurred in 4.7% (n=316) of patients receiving ertapenem and 2.6% of patients receiving comparator drug; however, these deaths were considered not drug-related.

Common (1% to 10%): Wound infection (6.5%), fever (up to 5%), edema/swelling (up to 3.4%), wound complication (2.9%), death (up to 2.5%), postoperative infection (2.3%)
Uncommon (0.1% to 1%): Greater than 0.5%: Crepitations, abdominal abscess, fungal rash, pelvic abscess, incision site complication, incision site hemorrhage, intestinal stoma complication, anastomotic leak, seroma, wound dehiscence, wound secretion; Greater than 0.1%: Abdominal distention, pain, chills, septicemia, septic shock, malaise, asthenia/fatigue, necrosis, candidiasis, facial edema, flank pain, flushing

Genitourinary

Common (1% to 10%): Urinary tract infection (3.8%), vaginitis (up to 3.3%), increased urine RBCs (up to 2.5%), increased urine WBCs (up to 2.5%)
Uncommon (0.1% to 1%): Greater than 0.5%: Dysuria, pollakiuria; Greater than 0.1%: Oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis
Frequency not reported: Presence of urine protein, increased urine epithelial cells

Urinary tract infection, dysuria, and pollakiuria were reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Respiratory

Common (1% to 10%): Atelectasis (3.4%), dyspnea (up to 2.6%), pneumonia (2.1%)
Uncommon (0.1% to 1%): Greater than 0.5%: Lung crackles, lung infiltration, pulmonary congestion, pulmonary embolism, wheezing; Greater than 0.1%: Cough, pharyngitis, rales/rhonchi, respiratory distress, pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, voice disturbance

Pneumonia, atelectasis, lung crackles, lung infiltration, pulmonary congestion, pulmonary embolism, and wheezing were reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Dermatologic

Common (1% to 10%): Rash (up to 2.5%), pruritus (up to 2%)
Uncommon (0.1% to 1%): Cellulitis (greater than 0.5%); Greater than 0.1%: Erythema, sweating, dermatitis, desquamation, urticaria
Postmarketing reports: Drug rash with eosinophilia and systemic symptoms (DRESS syndrome)

Cellulitis was reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Cardiovascular

Common (1% to 10%): Hypotension (up to 2%)
Uncommon (0.1% to 1%): Greater than 0.1%: Heart failure, hematoma, chest pain, hypertension, tachycardia, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, subdural hemorrhage

Musculoskeletal

Uncommon (0.1% to 1%): Muscle spasms (greater than 0.5%), gout (greater than 0.1%), leg pain (greater than 0.1%)
Postmarketing reports: Muscular weakness

Muscle spasms were reported in a study using 1 g of ertapenem for prophylaxis of surgical site infection following elective colorectal surgery.

Renal

Uncommon (0.1% to 1%): Greater than 0.1%: Renal impairment, increased serum creatinine, increased BUN

Metabolic

Uncommon (0.1% to 1%): Greater than 0.1%: Dehydration, weight loss, decreased serum potassium, decreased serum albumin, increased serum glucose, increased serum potassium, increased serum sodium
Frequency not reported: Decreased serum bicarbonate

Psychiatric

Uncommon (0.1% to 1%): Greater than 0.1%: Anxiety, nervousness, depression, aggressive behavior
Postmarketing reports: Altered mental status (including aggression, delirium), hallucinations

Hypersensitivity

Postmarketing reports: Anaphylaxis (including anaphylactoid reactions)

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